Medico-economic Evaluation of a Telemedicine System for the Management of Chronic Renal Failure (eNephro)

September 5, 2019 updated by: Pharmagest Interactive

The main objective of this study is to demonstrate the efficiency ( cost-effectiveness ) of a telemedicine system : eNephro Application , compared with traditional care in the management of chronic renal failure in different populations :

  • population 1 : Patients with CKD stage 3B- 4 , the combined endpoint achievement of target blood pressure and proteinuria .
  • population 2 : Patients with ESRD treated by ambulatory dialysis , the cumulative duration of hospitalization in short-stay
  • population 3 : Patients with ESRD treated with Renal Transplantation , the cumulative duration of unplanned short stay

Two statistical analysis will be done :

  • a main analysis for the one year initial follow-up for each patient
  • a secondary analysis for the one year initial follow-up estended by one year (proposed to each patient at the end of the initial follow-up), that is a 2 years period.

The intervention tested in this study is a telemedicine system which is a collaborative and expert system, consisting of:

  • A dynamic shared medical record for the collection of administrative , medical, biological and clinical data for each patient. All health professionals can access the folder and fill in the support. It is the same for patients treated at home.
  • A secure messaging for communication between health professionals and between patients and health professionals
  • Expert systems analyzing data from each patient
  • A management tool of therapeutic education

Each patient and whatever the group will perform as part of its monitoring of the CKD assessments at baseline , 6 months, 12 months, 18 months (Populations 1 and 2) and end of study (24 months). These evaluations are about compliance, quality of life, anxiety - depression state. To enhance costs the point of view retained will be health insurance's point of view. Among the various costs, only direct costs are considered: disease management, hospitalizations, consultations in hospitals and private practice, prescribed medical transportation , home visits by health professionals, additional assessments related to the evaluated intervention. A probabilistic matching with the data bases of the National Information System of the Social Insurance will be performed. In addition, the acceptability of the system of telemedicine by patients in the intervention and health professionals will be also evaluated.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Three populations are recruited with the following inclusion criteria:

  • age ≥ 18 years;
  • ability to use a tablet device (alone or with assistance);
  • population 1: stabilised stage 3B or stage 4 CKD with nephrology management of less than 3 years;
  • population 2: stage 5D CKD treated by homecare peritoneal dialysis (PD) or out centre haemodialysis (HD);
  • population 3: stage 5T CKD treated by renal transplantation for 3 to 12 months.

Non-inclusion criteria are:

  • dialysis after renal transplantation failure;
  • organ transplantation other than kidney;
  • life expectancy < 1 year.

Study Type

Interventional

Enrollment (Actual)

635

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bordeaux, France
        • CHU Bordeaux
      • Bordeaux, France
        • Aurad Aquitaine
      • Boulogne sur Mer, France
        • CH Boulogne sur Mer
      • Brest, France
        • TELECOM Bretagne
      • Dunkerque, France
        • Ch Dunkerque
      • Lille, France
        • CHU Lille
      • Nancy, France
        • Chu Nancy
      • Nancy, France
        • ALTIR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with CKD Stage 3B 4 ESRD patients receiving ambulatory dialysis , Patients treated with Renal Transplantation
  • In CKD patients stage 3B 4: nephrology care ≤ 3 years, for transplant patients: Renal Transplantation ≥ 3 months but ≤ 12 months
  • Patients can use an IT tool or having in their entourage one who knows how to use

Exclusion Criteria:

  • Acute Renal Failure at the time of inclusion
  • Patient in transplant failure
  • Patient with another organ transplant
  • Patient whose life is at stake in the short term (Life expectancy <1 year)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Traditional Care
Experimental: eNephro Application

Telemedicine system which is a collaborative and expert system, consisting of:

A dynamic shared medical record for the collection of administrative , medical, biological and clinical data for each patient. All health professionals can access the folder and fill in the support. It is the same for patients treated at home.

A secure messaging for communication between health professionals and between patients and health professionals Expert systems analyzing data from each patient A management tool of therapeutic education

These patients have a chronic renal failure moderate to end up being treated by ambulatory dialysis or kidney transplantation. The patients of each population will be randomly assigned in group 1 ie traditional care or in group 2 ie traditional care added by telemedicine system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Combined endpoint achievement of target blood pressure and proteinuria
Time Frame: one year
population 1 : Patients with CKD stage 3B- 4 , the combined endpoint achievement of target blood pressure and proteinuria
one year
Cumulative duration of hospitalization in short-stay for 1 year
Time Frame: one year
population 2 : Patients with ESRD treated by ambulatory dialysis , the cumulative duration of hospitalization in short-stay for 1 year
one year
Cumulative duration of unplanned short stay for 1 year
Time Frame: One year
population 3 : Patients with ESRD treated with Renal Transplantation , the cumulative duration of unplanned short stay for 1 year
One year
Survival
Time Frame: One Year
Population 2 : Survival without events event = hospitalization whatever the duration and/or return to in-center dialysis
One Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance
Time Frame: Base Line, 6 months, One Year
Girerd's auto questionnaire to assess compliance
Base Line, 6 months, One Year
Quality of Life of patients
Time Frame: Base Line, One Year
Populations 1 and 2 : KDQoL questionnaire to assess quality of life Population 3 : Re TRANSQoL questionnaire
Base Line, One Year
Anxiety-Depression State
Time Frame: Base Line, One Year
HAD Questionnaire
Base Line, One Year
Change in the glomerular filtration rate
Time Frame: Base Line, One Year
Population 1 : One Year Change in the GFR estimated by MDRD equation (delta GFR/year)
Base Line, One Year
Anemia Control
Time Frame: One Year
the anemia control is assessed by the achievement of hemoglobin, ferritin and saturation coefficient Transferrin targets
One Year
Change in the glomerular filtration rate
Time Frame: Base Line, One Year
Population 3 : One Year Change in the GFR estimated by MDRD equation (delta GFR/year)
Base Line, One Year
Consultations and Hospitalizations unplanned
Time Frame: One Year
Number of consultations and conventional hospitalizations unplanned in Transplantation center over a year
One Year
Disease's Costs
Time Frame: One Year

To enhance cost, the health insurance's point of a view is retained. Among the various costs, only direct costs are taken into account , there are :

  • costs associated with the management of the disease
  • hospitalizations' costs
  • consultations ' costs (hospital and liberal sectors)
  • prescribed medical transport's cost
  • health professional costs
  • additional tests costs. A probabilistic matching with the data bases of the National Information System of the Social Insurance will be performed. In addition, the acceptability of the system of telemedicine by patients in the intervention and health professionals will be also evaluated.
One Year
Intervention's costs
Time Frame: One Year
Costs related to the evaluated intervention : Costs installation, equipment , training and maintenance of the telemedicine system
One Year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: One Year
Acceptability questionnaire
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michèle Kessler, Pr, CHU Nancy, Nephrology Service

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

February 14, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 10, 2014

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 5, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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